Safety and Pharmacodynamic Effects of BIIB122 in Participants With LRRK2-Associated Parkinson's Disease (LRRK2-PD)
Purpose
This Phase 2a, multicenter, randomized, 12-week double-blind, placebo-controlled, parallel-group study, followed by an OLE, is designed to evaluate the safety, tolerability, and pharmacodynamic effects of BIIB122 in participants with LRRK2-PD. LRRK2-PD is defined as Parkinson's Disease (PD) in individuals who are heterozygous or homozygous carriers of a pathogenic LRRK2 variant that increases LRRK2 kinase activity.
Condition
- Parkinson Disease
Eligibility
- Eligible Ages
- Over 30 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- For heterozygous pathogenic LRRK2 mutation carriers: ≥ 30 to ≤ 80 years - For homozygous pathogenic LRRK2 mutation carriers: ≥ 30 years - Have screening genetic test results verifying the presence of a pathogenic LRRK2 variant. - Have a clinical diagnosis of PD meeting the Movement Disorder Society Clinical Diagnostic Criteria.
Exclusion Criteria
- Have a history of any clinically significant neurological disorder other than PD, including, but not limited to, stroke and dementia, in the opinion of the investigator, within 5 years of the screening visit. - Have clinical evidence of atypical parkinsonism (eg, multiple-system atrophy or progressive supranuclear palsy) or evidence of drug-induced parkinsonism. - Have previously participated or are currently participating in the BIIB122 LUMA study (Study 283PD201). - Have previously participated or are currently participating in a gene therapy study for PD. - Have a history of brain surgical intervention for PD (eg, deep-brain stimulation, pallidotomy). - Have any physical condition that may confound the motor assessment (MDS-UPDRS) over time (eg, severe arthritis, severe dyskinesias, traumatic injuries with permanent physical disability). - Abnormal vitals including Blood Pressure, Heart Rate, or Body Temperature - Have abnormal PFT results at screening Note: Other protocol defined Inclusion/Exclusion criteria may apply
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental BIIB122 225 mg |
Oral 225 mg dose, once daily (QD) |
|
|
Placebo Comparator BIIB122 Matching Placebo |
Oral BIIB122 matching placebo, once daily (QD) |
|
Recruiting Locations
Cedars-Sinai Department of Neurology
Los Angeles 5368361, California 5332921 90048
Los Angeles 5368361, California 5332921 90048
University of California San Francisco
San Francisco 5391959, California 5332921 94158
San Francisco 5391959, California 5332921 94158
Parkinson's Disease and Movement Disorders Center
Boca Raton 4148411, Florida 4155751 33486
Boca Raton 4148411, Florida 4155751 33486
Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215
Boston 4930956, Massachusetts 6254926 02215
Ichan School of Medicine at Mount Sinai/Beth Israel Downtown-Movement Disorder Center
New York 5128581, New York 5128638 10003
New York 5128581, New York 5128638 10003
Evergreen Health Laboratory
Kirkland 5799841, Washington 5815135 98034
Kirkland 5799841, Washington 5815135 98034
Inland Northwest Research
Spokane 5811696, Washington 5815135 99202
Spokane 5811696, Washington 5815135 99202
More Details
- NCT ID
- NCT06602193
- Status
- Recruiting
- Sponsor
- Denali Therapeutics Inc.